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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
510(k) Number K002803
Device Name THE O'NEIL STERILE FIELD URINARY CATHETER KIT
Applicant
Go Medical Industries Pty. , Ltd.
200 Churchill Ave.
Subiaco, Perth,  AU 6008
Applicant Contact GEORGE O'NEIL
Correspondent
Go Medical Industries Pty. , Ltd.
200 Churchill Ave.
Subiaco, Perth,  AU 6008
Correspondent Contact GEORGE O'NEIL
Regulation Number876.5130
Classification Product Code
FCM  
Subsequent Product Code
KOD  
Date Received09/08/2000
Decision Date 12/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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